NO347263B1 - Fremgangsmåte for fremstilling av en Faktor IX formulering for intravenøs injeksjon - Google Patents

Fremgangsmåte for fremstilling av en Faktor IX formulering for intravenøs injeksjon Download PDF

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Publication number
NO347263B1
NO347263B1 NO20082180A NO20082180A NO347263B1 NO 347263 B1 NO347263 B1 NO 347263B1 NO 20082180 A NO20082180 A NO 20082180A NO 20082180 A NO20082180 A NO 20082180A NO 347263 B1 NO347263 B1 NO 347263B1
Authority
NO
Norway
Prior art keywords
formulation
benefix
solution
agglutination
ionic strength
Prior art date
Application number
NO20082180A
Other languages
English (en)
Norwegian (no)
Other versions
NO20082180L (no
NO20082180A (no
Inventor
Chandra A Webb
Julie Zerfas
Original Assignee
Wyeth Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=37801586&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=NO347263(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Wyeth Llc filed Critical Wyeth Llc
Publication of NO20082180L publication Critical patent/NO20082180L/no
Publication of NO20082180A publication Critical patent/NO20082180A/no
Publication of NO347263B1 publication Critical patent/NO347263B1/no

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
NO20082180A 2005-11-01 2006-10-27 Fremgangsmåte for fremstilling av en Faktor IX formulering for intravenøs injeksjon NO347263B1 (no)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US73222105P 2005-11-01 2005-11-01
PCT/US2006/042258 WO2007053533A2 (en) 2005-11-01 2006-10-27 Sodium chloride solution for drug reconstitution or dilution

Publications (3)

Publication Number Publication Date
NO20082180L NO20082180L (no) 2008-07-04
NO20082180A NO20082180A (no) 2008-07-04
NO347263B1 true NO347263B1 (no) 2023-08-14

Family

ID=37801586

Family Applications (1)

Application Number Title Priority Date Filing Date
NO20082180A NO347263B1 (no) 2005-11-01 2006-10-27 Fremgangsmåte for fremstilling av en Faktor IX formulering for intravenøs injeksjon

Country Status (31)

Country Link
US (4) US20070135343A1 (es)
EP (3) EP3593790A1 (es)
JP (1) JP5555425B2 (es)
KR (2) KR20110128957A (es)
CN (1) CN101351190B (es)
AR (2) AR056748A1 (es)
AU (1) AU2006308921C1 (es)
BR (1) BRPI0618133A2 (es)
CA (1) CA2626531C (es)
CR (1) CR9958A (es)
DK (2) DK3225233T3 (es)
EC (1) ECSP088485A (es)
ES (2) ES2749574T3 (es)
FI (1) FI1942868T4 (es)
FR (1) FR20C1005I1 (es)
GT (1) GT200800037A (es)
HK (1) HK1245090B (es)
HU (4) HUE045421T2 (es)
IL (1) IL190843A (es)
LU (1) LUC00035I2 (es)
MY (1) MY184364A (es)
NO (1) NO347263B1 (es)
NZ (1) NZ567685A (es)
PE (3) PE20151284A1 (es)
PL (2) PL1942868T5 (es)
PT (2) PT3225233T (es)
RU (1) RU2432157C2 (es)
SI (2) SI1942868T2 (es)
TW (1) TWI480063B (es)
UA (1) UA97234C2 (es)
WO (1) WO2007053533A2 (es)

Families Citing this family (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL1942868T5 (pl) 2005-11-01 2023-12-27 Wyeth Llc Roztwór chlorku sodu do odtwarzania lub rozcieńczania leku
US7767206B2 (en) 2006-10-02 2010-08-03 Amgen Inc. Neutralizing determinants of IL-17 Receptor A and antibodies that bind thereto
US8431011B2 (en) * 2008-01-31 2013-04-30 Abbott Diabetes Care Inc. Method for automatically and rapidly distinguishing between control and sample solutions in a biosensor strip
EP2501367B1 (en) * 2009-11-17 2015-01-21 Ipsen Pharma S.A.S. Formulation for HGH and RHIGF-1 combination
US10634741B2 (en) 2009-12-04 2020-04-28 Endomagnetics Ltd. Magnetic probe apparatus
US9427186B2 (en) 2009-12-04 2016-08-30 Endomagnetics Ltd. Magnetic probe apparatus
PH12012501364A1 (en) 2010-01-15 2012-10-22 Amgen K A Inc Antibody formulation and therapeutic regimens
NZ602685A (en) 2010-03-01 2014-10-31 Cytodyn Inc Concentrated protein formulations and uses thereof
PL3552619T3 (pl) 2010-07-09 2025-12-01 Bioverativ Therapeutics Inc. Polipeptydy czynnika ix i sposoby ich zastosowania
HK1213521A1 (zh) * 2012-09-25 2016-07-08 Bioverativ Therapeutics Inc. Fix多肽的應用
ES2803506T3 (es) 2013-03-11 2021-01-27 Endomagnetics Ltd Soluciones hipoosmóticas para la detección de ganglios linfáticos
US9234877B2 (en) 2013-03-13 2016-01-12 Endomagnetics Ltd. Magnetic detector
US9239314B2 (en) 2013-03-13 2016-01-19 Endomagnetics Ltd. Magnetic detector
WO2014144549A1 (en) * 2013-03-15 2014-09-18 Biogen Idec Ma Inc. Factor ix polypeptide formulations
FR3005420B1 (fr) 2013-05-07 2015-09-18 Erytech Pharma Procede de stabilisation de suspensions d'erythrocytes encapsulant un principe actif, suspensions obtenues.
AU2015236340B2 (en) * 2014-03-24 2020-02-06 Bioverativ Therapeutics Inc. Lyophilized factor IX formulations
US9351945B1 (en) 2015-02-27 2016-05-31 John Daniel Dobak, III Reduction of adipose tissue
GB2536703B (en) * 2015-03-27 2020-12-02 Ge Healthcare Bio Sciences Ab Method for baseline correction in a chromatogram
EP3081942A1 (en) * 2015-04-17 2016-10-19 Roche Diagniostics GmbH Pressure transmission liquid for cellular analyzer, cellular analyzer and method for analyzing a liquid cellular sample
MX390935B (es) 2015-06-04 2025-03-21 Endomagnetics Ltd Materiales marcadores y formas para la localización de marcadores magnéticos (mml).
US10124021B2 (en) * 2016-12-23 2018-11-13 Andrew L. Gostine Intravenous fluid
JP7110360B2 (ja) 2017-10-09 2022-08-01 テルモ ビーシーティー バイオテクノロジーズ，エルエルシー 凍結乾燥方法
CN113597532B (zh) 2019-03-14 2023-02-17 泰尔茂比司特生物技术有限公司 冻干容器填充固定装置、系统及使用方法
US12036187B2 (en) * 2019-05-01 2024-07-16 Southwest Research Institute Compositions of dimethyl trisulfide (DMTS) as a cyanide antidote
WO2021108051A2 (en) * 2019-10-25 2021-06-03 Cmc Pharmaceuticals, Inc. Atropine-scopolamine with enhanced stability
IL272145A (en) * 2020-01-20 2021-07-29 Stem Cell Medicine Ltd Cosmetic compositions with protein concentrate from conditioned medium of adipose-derived stem cells
JP2023538831A (ja) * 2020-08-03 2023-09-12 トランスルミナル、システムズ、リミテッド、ライアビリティー、カンパニー 病理組織の経動脈浸透圧塞栓形成のためのデバイスおよび方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3717708A (en) * 1968-10-24 1973-02-20 Cutter Lab Blood coagulation complex
WO2005058283A2 (en) * 2003-12-19 2005-06-30 Novo Nordisk Health Care Ag Stabilised compositions of factor vii polypeptides
WO2005089712A1 (en) * 2004-03-04 2005-09-29 Wyeth Lyophilization method to improve excipient crystallization

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4364861A (en) 1980-05-27 1982-12-21 Cutter Laboratories, Inc. Blood-coagulation-promoting products and methods of preparing them
US6372716B1 (en) 1994-04-26 2002-04-16 Genetics Institute, Inc. Formulations for factor IX
DK1820516T3 (da) 1999-02-22 2013-10-28 Univ Connecticut Nye albuminfrie faktor VIII-præparater
US20010031721A1 (en) * 1999-05-05 2001-10-18 Chandra Webb Highly concentrated, lyophilized, and liquid factor IX formulations
AU2002213441B2 (en) * 2000-10-12 2006-10-26 Genentech, Inc. Reduced-viscosity concentrated protein formulations
PL1942868T5 (pl) 2005-11-01 2023-12-27 Wyeth Llc Roztwór chlorku sodu do odtwarzania lub rozcieńczania leku

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3717708A (en) * 1968-10-24 1973-02-20 Cutter Lab Blood coagulation complex
WO2005058283A2 (en) * 2003-12-19 2005-06-30 Novo Nordisk Health Care Ag Stabilised compositions of factor vii polypeptides
WO2005089712A1 (en) * 2004-03-04 2005-09-29 Wyeth Lyophilization method to improve excipient crystallization

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
"International Blood/Plasma News", vol. 18, utgave 9, april 2001, side 127 , Dated: 01.01.0001 *
BUSH L ET AL: "THE FORMULATION OF RECOMBINANT FACTOR IX: STABILITY, ROBUSTNESS, AND CONVENIENCE" SEMINARS IN HEMATOLOGY, PHILADELPHIA, PA, US, vol. 35, no. 2, SUPPL 2, 1998,side 18-21, XP001010494, ISSN: 0037-1963 , Dated: 01.01.0001 *
Constantino H. and Pikal M. "Lyophilisation of Biopharmaceuticals", American Association of Pharmaceutical Scientist, USA, 2004, side 197-198, ISBN: 0-9711767-6-0, Dated: 01.01.0001 *
VAN DEN BERG H M ET AL: "BeneFixTM induces agglutination of red cells" BLOOD, W.B.SAUNDERS COMPANY, ORLANDO, FL, US, vol. 96, nr. 11 del 1, 2000, side 641a, XP008083763, ISSN: 0006-4971, Dated: 01.01.0001 *

Also Published As

Publication number Publication date
DK1942868T4 (da) 2023-11-06
UA97234C2 (ru) 2012-01-25
TWI480063B (zh) 2015-04-11
BRPI0618133A2 (pt) 2011-08-16
IL190843A (en) 2013-08-29
ECSP088485A (es) 2008-06-30
TW200803915A (en) 2008-01-16
AR112443A2 (es) 2019-10-30
US20070135343A1 (en) 2007-06-14
DK1942868T3 (en) 2017-06-26
SI1942868T1 (sl) 2017-07-31
PL1942868T5 (pl) 2023-12-27
EP3225233A1 (en) 2017-10-04
HUE033949T2 (hu) 2018-01-29
US20200338199A1 (en) 2020-10-29
PT1942868T (pt) 2017-06-16
IL190843A0 (en) 2008-11-03
LUC00035I2 (es) 2017-12-01
PL3225233T3 (pl) 2019-12-31
CN101351190A (zh) 2009-01-21
KR101126670B1 (ko) 2012-04-23
PL1942868T3 (pl) 2017-09-29
JP2009513705A (ja) 2009-04-02
SI1942868T2 (sl) 2023-12-29
CN101351190B (zh) 2013-01-02
EP1942868B2 (en) 2023-10-04
ES2749574T3 (es) 2020-03-23
PE20151284A1 (es) 2015-10-05
FI1942868T4 (fi) 2023-10-12
WO2007053533A8 (en) 2008-07-24
US20170021022A1 (en) 2017-01-26
RU2008119514A (ru) 2009-12-10
PT3225233T (pt) 2019-10-24
HUS1700035I1 (hu) 2017-11-28
KR20110128957A (ko) 2011-11-30
AR056748A1 (es) 2007-10-24
ES2627684T3 (es) 2017-07-31
PE20070714A1 (es) 2007-07-20
EP3593790A1 (en) 2020-01-15
FR20C1005I1 (fr) 2020-03-20
LUC00035I1 (es) 2017-09-28
RU2432157C2 (ru) 2011-10-27
CA2626531A1 (en) 2007-05-10
HUS2000003I1 (hu) 2020-02-28
WO2007053533A2 (en) 2007-05-10
MY184364A (en) 2021-04-01
AU2006308921A1 (en) 2007-05-10
HUE045421T2 (hu) 2019-12-30
CR9958A (es) 2008-07-29
KR20080065689A (ko) 2008-07-14
NZ567685A (en) 2011-07-29
US20200138952A1 (en) 2020-05-07
AU2006308921C1 (en) 2013-01-24
CA2626531C (en) 2011-11-29
JP5555425B2 (ja) 2014-07-23
DK3225233T3 (da) 2019-10-14
AU2006308921B2 (en) 2012-07-19
SI3225233T1 (sl) 2019-10-30
EP1942868A2 (en) 2008-07-16
NO20082180L (no) 2008-07-04
ES2627684T5 (es) 2024-04-29
HK1245090B (en) 2020-04-09
EP1942868B1 (en) 2017-04-19
EP3225233B1 (en) 2019-08-14
PE20110803A1 (es) 2011-11-07
DK1942868T5 (da) 2024-01-08
WO2007053533A3 (en) 2007-12-06
NO20082180A (no) 2008-07-04
GT200800037A (es) 2008-10-01

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Owner name: WYETH LLC, US